Palliative Care in the ICU

Palliative Care Clinical Trial

Official title:

Early Palliative Care in the Medical Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263143
• Other study ID #: 201707067
• Status: Completed
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study compares early palliative care consultation to standard of care in the medical intensive care unit (ICU). The study will assess if the intervention leads to an increased proportion of clearly delineated goals of care and examine if this intervention leads to decreased healthcare resource utilization such as length of stay, duration of intensive treatments including mechanical ventilation, and hospital re-admissions.

Description:

• The medical intensive care unit will be split into two groups, assigned as either early palliative care consultation or standard of care. Current standard of care in the ICU is that primary clinician providers determine the need and time for palliative care consultation, which can occur approximately 5 - 14 days after admission.

• A palliative care screening tool will be used to determine if a newly admitted patient is eligible for palliative care consultation.

• Up to two patients per ICU per weekday will be enrolled into the study, due to workload limitations on the palliative care consult team.

• For patients in the intervention group, a palliative care consultation will be performed within 48 hours of ICU admission and patients will be followed throughout their hospitalization.

• Patients in the standard of care group will receive usual care. Palliative care may be consulted at the primary team's clinical discretion.

• The two medical ICU groups will be crossed over after three months with a washout period of six weeks, for a total of approximately eight months of study

• Electronic medical records will be reviewed after patient discharge to collect data on clinical outcomes as described elsewhere

Other known NCT identifiers

• NCT03210116

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: November 30, 2018
• Est. primary completion date: June 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admitted to the ICU in the last 24 hours

• Admitted from Skilled nursing facility (SNF), long term acute care (LTAC)facility, long term ventilator care (vent LTC) unit, or home care with private duty nursing with activity of daily living (ADL) dependencies

• End-stage dementia, amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis

• Advanced or Metastatic Cancer

• Cardiac or respiratory arrest with neurological compromise

• Multi- organ system failure (more than 2 organ failures)

• Known diagnosis of end stage organ disease including cirrhosis, end-stage renal disease, congestive heart failure New York Heart Association >III, chronic obstructive pulmonary disease on home O2

• Shock requiring > 6 hours of vasopressors or inotropes

• Acute Respiratory failure requiring intubation or BiPAP

• Admitted to ICU with hospital length of stay of more than 5 days or ICU readmission with the same diagnosis in 30 days.

Exclusion Criteria:

• All stem cell transplant patients, for solid organ transplant, if undergoing evaluation for solid organ transplant or within 1 year post-transplant.

• Patients who do not speak English if interpreter is unavailable

• Patients without capacity to participate in palliative care discussions without a surrogate available

• Patients or patient surrogate refusal of palliative care consultation

• Prior Palliative Care Consultation during the same hospitalization

• For purposes of primary outcome analysis, patients determined to already be DNR/DNI at time of ICU admission

Related Conditions & MeSH terms

• Palliative Care

Intervention

Other:
• Palliative Care
Palliative Care Consultation within 24 to 48 hours after admission

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (8)

Adelson K, Paris J, Horton JR, Hernandez-Tellez L, Ricks D, Morrison RS, Smith CB. Standardized Criteria for Palliative Care Consultation on a Solid Tumor Oncology Service Reduces Downstream Health Care Use. J Oncol Pract. 2017 May;13(5):e431-e440. doi: 10.1200/JOP.2016.016808. Epub 2017 Mar 17. — View Citation

Aslakson R, Cheng J, Vollenweider D, Galusca D, Smith TJ, Pronovost PJ. Evidence-based palliative care in the intensive care unit: a systematic review of interventions. J Palliat Med. 2014 Feb;17(2):219-35. doi: 10.1089/jpm.2013.0409. Review. — View Citation

Braus N, Campbell TC, Kwekkeboom KL, Ferguson S, Harvey C, Krupp AE, Lohmeier T, Repplinger MD, Westergaard RP, Jacobs EA, Roberts KF, Ehlenbach WJ. Prospective study of a proactive palliative care rounding intervention in a medical ICU. Intensive Care Med. 2016 Jan;42(1):54-62. doi: 10.1007/s00134-015-4098-1. Epub 2015 Nov 10. — View Citation

Hsu-Kim C, Friedman T, Gracely E, Gasperino J. Integrating Palliative Care into Critical Care: A Quality Improvement Study. J Intensive Care Med. 2015 Sep;30(6):358-64. doi: 10.1177/0885066614523923. Epub 2014 Mar 5. — View Citation

Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015 May;43(5):1102-11. doi: 10.1097/CCM.0000000000000852. Review. — View Citation

Kyeremanteng K, Gagnon LP, Thavorn K, Heyland D, D'Egidio G. The Impact of Palliative Care Consultation in the ICU on Length of Stay: A Systematic Review and Cost Evaluation. J Intensive Care Med. 2018 Jun;33(6):346-353. doi: 10.1177/0885066616664329. Epub 2016 Aug 31. Review. — View Citation

Mun E, Ceria-Ulep C, Umbarger L, Nakatsuka C. Trend of Decreased Length of Stay in the Intensive Care Unit (ICU) and in the Hospital with Palliative Care Integration into the ICU. Perm J. 2016 Fall;20(4):56-61. doi: 10.7812/TPP/16-036. Epub 2016 Aug 31. — View Citation

Penrod JD, Pronovost PJ, Livote EE, Puntillo KA, Walker AS, Wallenstein S, Mercado AF, Swoboda SM, Ilaoa D, Thompson DA, Nelson JE. Meeting standards of high-quality intensive care unit palliative care: clinical performance and predictors. Crit Care Med. 2012 Apr;40(4):1105-12. doi: 10.1097/CCM.0b013e3182374a50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in code status to do-not-resuscitate/do-not-intubate	As determined by code status orders in the electronic medical record	Through patient admission until discharge, charts reviewed an average of one month after discharge
Secondary	Number of participants with Cardiopulmonary Resuscitation (CPR) performed		Through study completion, an average of 6 months
Secondary	Mechanical Ventilation usage and duration		After date of discharge, charts reviewed an average of one month after discharge
Secondary	Hospital Length of Stay		After date of discharge, charts reviewed an average of one month after discharge
Secondary	ICU Length of Stay		After date of discharge, charts reviewed an average of one month after discharge
Secondary	In-hospital mortality	Excluding patients transitioned to hospice prior to death	After date of discharge, charts reviewed an average of one month after discharge
Secondary	30-day mortality	Including all patients, including those on hospice	One to two months after patient discharge, verified at study completion
Secondary	Hospice transition or discharge		Through patient admission until discharge, charts reviewed an average of one month after discharge
Secondary	Post-discharge ER visits and/or readmissions	Determined by review of the BJC healthcare system electronic medical record	One to two months after patient discharge, verified at study completion
Secondary	Total hospital operating cost		Through study completion, an average of 6 months
Secondary	Vasopressor usage and duration		After date of discharge, charts reviewed an average of one month after discharge
Secondary	Antibiotic usage and duration		After date of discharge, charts reviewed an average of one month after discharge
Secondary	Number of participants treated with hemodialysis		Through study completion, an average of six months
Secondary	Number of participants with tracheostomy performed during hospital stay		Through study completion, an average of six months